510(k) K030719 ยท MXK Device, Analysis, Anterior Segment
PENTACAM SCHEIMPFLUG CAMERA
| Applicant | Oculus Optikgerate GmbH, Woodinville WA, US |
| Decision | Substantially Equivalent, Sep 16, 2003 |
| Received | Mar 7, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030719
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 8, 2022 | Oculus Optikgeraete GMBH Pentacam HR REF 70900. Used to image the anterior segment of the eye. Open, Classified |
MXK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.